BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 3063306 · Received April 11, 2013

    Report

    Report Number
    1037905-2013-00140
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 14, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. ACCORDING TO THE REPORT LUBRICATION AND NEGATIVE PRESSURE WERE NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THE INSTRUCTIONS FOR USE STATES: "TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE, APPLY NEGATIVE PRESSURE TO THE CATHETER." APPLYING A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. A POSSIBLE CONTRIBUTING FACTOR TO BALLOON MATERIAL RUPTURE IS INADEQUATE LUBRICATION OF THE BALLOON WITH A WATER SOLUBLE LUBRICANT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A WATER SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT NEGATIVE PRESSURE IS MANDATORY TO MAINTAIN BALLOON DEFLATION. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. A BALLOON MATERIAL SPLIT CAN OCCUR IF THE BALLOON IS INFLATED PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE OR IF THE BALLOON IS INFLATED WHILE PARTIALLY OR FULLY INSIDE THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "DO NOT PRE-INFLATE THE BALLOON." THE INSTRUCTIONS FOR USE ALSO CONTAIN THE FOLLOWING PRECAUTION: "MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE UNTIL THE DILATOR IS COMPLETELY VISUALIZED ENDOSCOPICALLY." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFORMATION: "THE BALLOON CAN BE INFLATED TO THREE DISTINCT DIAMETERS, AS INDICATED ON THE PACKAGE AND CATHETER TAG. DO NOT EXCEED THE MAXIMUM INDICATED INFLATION PRESSURE." OVER INFLATION CAN CAUSE DAMAGE TO THE BALLOON DILATOR, SUCH AS A RUPTURE OR SPLIT. ANOTHER POSSIBLE CONTRIBUTING FACTOR IS USING A COMPROMISED INFLATION DEVICE TO INFLATE THE BALLOON. IF THE PRESSURE READING OF THE INFLATION DEVICE IS INACCURATE, THIS COULD CONTRIBUTE TO OVER INFLATION, POSSIBLY RESULTING IN A RUPTURE OF THE BALLOON MATERIAL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE ESOPHAGEAL BALLOONS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL DILATION PROCEDURE, A COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON WAS USED. THE BALLOON WAS ADVANCED THROUGH THE ENDOSCOPE AND INFLATED WITH WATER. THE BALLOON BURST UPON INFLATING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. USING A 60CC SYRINGE AND DILATION HANDLE THE BALLOON WAS INFLATED WITH WATER. A STREAM OF WATER COULD BE SEEN EXITING THE BALLOON AT THE PROXIMAL BALLOON NECK ATTACHMENT POINT TO THE CATHETER. THE BALLOON WILL NOT HOLD A STEADY PRESSURE AND DILATION PERFORMANCE IS LIKELY COMPROMISED IN THIS CONDITION DUE TO THE SLOW LOSS OF PRESSURE. THERE WAS NO PART OF THE BALLOON MISSING. THE APPEARANCE OF THE DAMAGED AREA SUGGESTS THE BALLOON MAY HAVE COME INTO CONTACT WITH A SHARP OBJECT, PERHAPS A SHARP EDGE OF THE ENDOSCOPE USED WITH THIS BALLOON DILATOR. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155486 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W3225784

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIFH 180J ENDOSCOPE| DILATION SYRINGE